CN102764169B - Cardiac valve prosthesis and valve bracket thereof - Google Patents

Abstract

The present invention discloses a kind of Cardiac valve prosthesis and valve bracket thereof, and described valve bracket is can the elastic support of axial shrinkage, and in Openworks shape, the position that described valve bracket correspondence arranges lobe leaf forms U-shaped opening.The present invention, by arranging Openworks shape and having the valve bracket of U-shaped opening, makes cardiac valve bulk metal structure greatly reduce, and is extremely conducive to the loading getting involved and implant and recovery, reduces human body to the repellency of implantable.

Description

Cardiac valve prosthesis and valve bracket thereof

Technical field

The present invention relates to medical instruments field, particularly relate to a kind of Cardiac valve prosthesis and valve bracket thereof.

Background technology

The cause of disease of valvular heart disease can be divided into congenital and posteriority two class.Congenital Heart valvular heart disease is due to valve dysplasia during birth or hypoplasia.Such as, aortic valve two lobeization deformity, can cause aortic stenosis or incompetence.If aortic stenosis or incompetence, seriously will affect hemodynamic responses, and cause Progressive symmetric erythrokeratodermia valvular function to fail, finally cause heart failure, dead.The roughly cause of disease of posteriority valvular heart disease can be divided into infection, degeneration, rheumatological to change or other reasons.Infection is that antibacterial arrives endocardial by blood and invades valve; Degeneration is that valve can be degenerated gradually, the most common with aortic valve along with the age is gradually long; Rheumatological change mainly refers to rheumatic heart disease, due to streptococcal infection, then causes immunoreation and destroys cardiac valve.Other reason can comprise wound, chordae tendineae spontaneous rupture etc.The surgical operation therapy of current treatment valvular heart disease mainly divides two kinds: one is valvoplasty, namely repairs the valve of infringement; Another kind is prosthetic valve replacement, namely carries out valve replacement with Cardiac valve prosthesis.

General prosthetic valve replacement is all undertaken by surgical operation.Although wound is comparatively large, operation is ripe, and success rate of operation is high, and complication rate is low.Current Cardiac valve prosthesis is categorized as two kinds, and one is mechanical prosthetic valve, and one is bioprosthetic valve.Bioprosthetic valve at protection blood, safeguard and be far superior to mechanical prosthetic valve in normal hemodynamics etc.; Bioprosthetic valve does not need lifelong oral anticoagulation thing, and mechanical prosthetic valve needs lifelong oral anticoagulation thing.Although bioprosthetic valve persistency aspect be inferior to mechanical prosthetic valve, along with the progress of bioprosthetic valve design and the technology such as lobe leaf anticalcium process, the durability of bioprosthetic valve progressively improves.Therefore, the developing direction of current valve be no matter in the world or domestic all clearly, that is, the application of bioprosthetic valve progressively will replace mechanical prosthetic valve.

But there is following several respects problem in existing bioprosthesis valve in surgical replacement process:

(1) size is not collapsible.Because all structures of current all bioprosthetic valve lobes are rigid structural, and the model of artificial valve is limited, cannot meet the valve demand of Different age group, different weight and different lesions form completely.For when cannot mate completely, doctor usually selects the artificial valve being slightly less than lobe week, and its problem brought is that suture ligature is easily beaten and torn, and fixing unstable, nearly perivalvular leakage at a specified future date also easily occurs.If the model selected is excessive, then rigid snapping in easily is caused the tearing of heart tissue, is damaged.So in this case, must add and do lobe widening of the ring art, add operation risk so undoubtedly.Particularly child or teenager, because lobe ring is little, the bioprosthetic valve of ting model is selected during operation, but along with the growth of age, body weight, the valve that model is fixed cannot meet hemodynamics demand further, therefore need regularly to carry out prosthetic valve replacement, to change larger bioprosthetic valve, this not only adds surgery cost, also increases operation misery and operation risk;

(2) operation stitching difficulty.During bioprosthetic valve displacement, valve is seamed to active position, at least needs 12 ~ 15 pins.Therefore, to how better, quickly to sew up in operation process, reduce the wound relevant to operation and shorten cardiopulmonary bypass time etc., being proposed higher requirement.Obviously, every many seams one pin all can increase operation risk.

And relative to operating deficiency, little with its wound by the mode of intervene operation implanted prosthetic heart valve, few and more and more paid close attention to the invasive of human body.But so far, carry out valve replacement in the mode of Wicresoft's intervention apparatus and Problems existing is more: (1), if position is not good behind valve location, will be blocked heart coronary artery opening, and cause acute myocardial infarction; (2) if do not fix after valve release, directly can come off, slide into ascending aorta, cause ascending aorta and corresponding trunk bifurcated thereof to block.And the problems referred to above all likely cause death, apoplexy, the severe complications such as organ failure, risk is still difficult to control, and risk, once occur, cannot make up.

Summary of the invention

Main purpose of the present invention is to provide a kind of valve bracket, and the Cardiac valve prosthesis being intended to this valve bracket is formed both can be used in intervene operation, and also can be used in Srgery grafting operation, and intervene operation is safer, implant surgery is faster.

The invention provides a kind of valve bracket of Cardiac valve prosthesis, described valve bracket is can the elastic support of axial shrinkage, and described valve bracket is Openworks shape, and the position of the corresponding lobe leaf of described valve bracket arranges U-shaped opening.

Preferably, the U-shaped lower opening portion of described valve bracket is provided with location structure.

Preferably, described location structure comprises and being set to the concave by valve bracket and the recessed portion that formed, and described recessed portion is used for coordinating with position of valve, limits the slip of described valve bracket.

Preferably, described location structure comprises and outwards to be extended the holding division formed by valve bracket, and described holding division is fastened on position of valve place, limits described valve bracket and slides.

Preferably, described location structure comprises the sutural margin positioned in position of valve for valve bracket.

Preferably, described sutural margin is half drum sutural margin, and the material of this sutural margin is water swelling material; Or described sutural margin is undaform sutural margin.

Preferably, described U-shaped open top end upwards extends and also arranges extension.

Preferably, the root of described U-shaped opening outwards extends.

Preferably, the lower end of the U-shaped mouth of described valve bracket is provided with hollow out mouth.

Preferably, the upper end of described valve bracket is provided with connecting portion, form described U-shaped opening, and the outer wall of connecting portion is provided with overlay film between described two adjacent connecting portions; The lower end of described valve bracket is inner buckle structure.

Present invention also offers a kind of Cardiac valve prosthesis, comprise lobe leaf and support the valve bracket of described lobe leaf, described valve bracket is can the elastic support of axial shrinkage, and described valve bracket is Openworks shape, and the position of the corresponding lobe leaf of valve bracket arranges U-shaped opening.

The present invention, by arranging Openworks shape and having the valve bracket of U-shaped opening, makes cardiac valve bulk metal structure greatly reduce, and is extremely conducive to the loading getting involved and implant and recovery, reduces human body to the repellency of implantable.

The present invention also by the location structure that valve bracket outer wall is arranged, thus makes this location structure can be adaptive with position of valve, and valve bracket can be located better.

The present invention is also by arranging sutural margin at valve bracket outer wall, and efficiently solving the lobe ring of Cardiac valve prosthesis that existing surgical operation implants is rigid structural, the limited grade of model and not of uniform size, the different contradiction of patient's heart lobe ring.Meanwhile, self-expansion type support (can adopt memorial alloy) has the growth with health, chronic dilatation, the characteristic adapted to voluntarily.In operation process, operation is simpler, more convenient, thus reaches shortening operating time, reduces the object of operation risk.In addition, lobe body and lobe frame can reduce better, are more easily positioned in lobe ring, thus avoid the possibility of row lobe widening of the ring art.

The present invention is also outwards extended by the root of U-shaped opening, thus can strut the blood vessel of fitting with valve bracket, reduces Cardiac valve prosthesis after long-term use, blocks up the probability of arteria coronaria because of fatigue damage.

The extension that the present invention is also upwards extended by U-shaped open top end and formed, makes this extension better supplemental support at ascending artery place, thus to make cardiac valve more stable, keeps blood to flow to.

The present invention also arranges overlay film by the outer wall of U-shaped open top end, thus can prevent metal termination from contacting with blood vessel, thus thorn mill blood vessel.

The present invention also arranges the hollow out mouth corresponding with arteria coronaria mouth by the bottom of U-shaped opening, thus ensure that blood flow is more smooth and easy, avoids the generation that intermittent arteria coronaria blocks.

Accompanying drawing explanation

Fig. 1 is the structural representation of Cardiac valve prosthesis first embodiment of the present invention;

Fig. 2 is the structural representation of Cardiac valve prosthesis second embodiment of the present invention;

Fig. 3 is the structural representation of Cardiac valve prosthesis of the present invention 3rd embodiment;

Fig. 4 is the structural representation of Cardiac valve prosthesis of the present invention 4th embodiment;

Fig. 5 is the structural representation of Cardiac valve prosthesis of the present invention 5th embodiment;

Fig. 6 is the plan structure schematic diagram of Cardiac valve prosthesis shown in Fig. 1;

Fig. 7 is the structural representation of Cardiac valve prosthesis of the present invention 6th embodiment;

Fig. 8 is the structural representation of Cardiac valve prosthesis of the present invention 7th embodiment.

The realization of the object of the invention, functional characteristics and advantage will in conjunction with the embodiments, are described further with reference to accompanying drawing.

Detailed description of the invention

Technical scheme of the present invention is further illustrated below in conjunction with Figure of description and specific embodiment.Should be appreciated that specific embodiment described herein only in order to explain the present invention, be not intended to limit the present invention.

With reference to the structural representation that Fig. 1, Fig. 1 are Cardiac valve prosthesis first embodiments of the present invention.This inventive embodiments Cardiac valve prosthesis comprises lobe leaf 20 and supports the valve bracket 10 of lobe leaf 20.This valve bracket 10 is netted hollow out support, is made up of elastomeric material, and can axial stretching.And lobe leaf 20 is made up of polymeric biomaterial or biological tissue.The position of the corresponding lobe leaf of valve bracket 10 arranges U-shaped opening 30.This lobe leaf 20 is 2-3 lobe.The embodiment of the present invention is for aortic valve, and its lobe leaf is 3 lobes, and U-shaped opening 30 corresponding on corresponding valve bracket 10 is also 3.The root of this U-shaped opening 30 extends to the over half of lobe leaf 20, extends at most the root of lobe leaf 20.

Valve bracket 10 comprises upper end 11 and lower end 12, and wherein lower end 12 is blood inflow place.Upper end 11 comprises the connecting portion 111 arranging lobe leaf 20, and forms above-mentioned U-shaped opening 30 between this two connecting portion 111.The edge of this U-shaped opening 30 is the arc transition muscle connecting adjacent two connecting portions 111, so can reduce stress and concentrate, and avoids valve bracket 10 to rupture because of tired.

The embodiment of the present invention, by arranging Openworks shape and having the valve bracket of U-shaped opening, makes cardiac valve bulk metal structure greatly reduce, and is extremely conducive to the loading getting involved and implant and recovery, and reduces the repellency of human body to implant.

U-shaped opening 30 bottom of above-mentioned valve bracket 10 is also provided with the location structure for being coordinated with position of valve by valve bracket 10, i.e. the junction of upper end 11 and lower end 12.In the present embodiment, this location structure comprises and being set to the concave by the outer wall of valve bracket 10 and the recessed portion 41 that formed, and this recessed portion 41 can coordinate with position of valve, limits described valve bracket and slides.Because valve bracket 10 is elastic support, so after this valve bracket be contracted in sheath pipe is transported to position of valve place, when departing from sheath pipe, valve bracket 10 elasticity is opened, thus make this recessed portion 41 also can with position of valve resilient engagement, restriction valve bracket 10 slides.

With reference to the structural representation that Fig. 2, Fig. 2 are Cardiac valve prosthesis second embodiments of the present invention.Be with the difference of the first embodiment: location structure only can also comprise the holding division 42 that support extension is formed; Or be combined with recessed portion 41 location structure forming valve bracket by holding division 42.When placing this cardiac valve with intervening mode, the lobe leaf of human body is still retained in original position (i.e. position of valve), then human body lobe leaf can snap in wherein by holding division 42, the slip of restriction valve bracket, thus achieves the location of valve bracket 10.If holding division 42 and recessed portion 41 in conjunction with time, recessed portion 41 also coordinates with position of valve, further enhances the location of valve bracket 10.

With reference to the structural representation that Fig. 3, Fig. 3 are Cardiac valve prosthesis of the present invention 3rd embodiments.Be with the difference of first, second embodiment: location structure can also comprise sutural margin 43, sutural margin 43 comprises suturing part 431, and sutural margin 43 is the ring-type with valve bracket 10 adaptation, as shown in Figure 3.Sutural margin 43 is mainly used in the displacement of the Cardiac valve prosthesis in surgical operation.Such as, after heart is opened, first diseased valve is excised, suturing part 431 and human body lobe circumferential weld are closed, finally heart, thoracic cavity are sewed up.

The present invention by arranging sutural margin 43 on the outer wall of valve bracket 10, and the lobe ring efficiently solving the Cardiac valve prosthesis that existing surgical operation is implanted is rigid structural, the limited grade of model and not of uniform size, the different contradiction of patient's heart lobe ring.Meanwhile, self-expansion type support (can adopt memorial alloy) has the growth with health, chronic dilatation, the characteristic adapted to voluntarily.In operation process, operation is simpler, more convenient.Thus reach shortening operating time, reduce the object of operation risk.In addition, lobe body and lobe frame can self adaptation lobe ring sizes better, coordinate, thus avoid the possibility of row lobe widening of the ring art with human body lobe ring.

With reference to the structural representation that Fig. 4, Fig. 4 are Cardiac valve prosthesis of the present invention 4th embodiments.Be with the difference of the 3rd embodiment: this sutural margin 43 is wave sutural margin.This sutural margin 43 is in wavy, and the inwall of sutural margin 43 is fitted in the outer wall of valve bracket 10.Lobe ring due to human body is not a smooth cross section, therefore corrugated sutural margin can coordinate the lobe ring with out-of-flatness cross section, can be tightr with lobe loop contacts by the sutural margin 43 of this undulate, and can fit better with primary lobe, thus reduce the probability of perivalvular leakage.This corrugated sutural margin 43 is also mainly used in the displacement of the Cardiac valve prosthesis in surgical operation.Such as, after heart is opened, first diseased valve is excised, corrugated sutural margin 43 is closed with human body lobe circumferential weld, finally heart and thoracic cavity are sewed up.

With reference to the structural representation that Fig. 5, Fig. 5 are Cardiac valve prosthesis of the present invention 5th embodiments.Be with the difference of the 3rd, the 4th embodiment: this sutural margin 43 is half drum sutural margin.This sutural margin 43 is provided with groove 432, and this groove 432 can be adaptive with lobe ring.After heart is opened, first diseased valve is excised, then by Cardiac valve prosthesis by groove 432, be placed on the correct position of lobe ring, and this groove 432 is also formed with lobe ring and engages, and then groove 432 two side and lobe circumferential weld are closed, finally heart and thoracic cavity are sewed up.Groove 432 due to this sutural margin 43 can be formed with lobe ring and engage, so when carrying out sutural margin 43 and closing with lobe circumferential weld, can reduce sewing needle number, thus reach shortening operating time, reduces the object of operation risk.In addition, this sutural margin also has the characteristic of water-swellable, can fit tightly after implantation with tissue.Or this sutural margin also has climbs to valve bracket the characteristic covered and degrade gradually with tissue.Therefore, the Cardiac valve prosthesis with this half drum sutural margin can also be used for insertion type mode.Such as, deliver to suitable position by conveyer device, sutural margin 43 water-swellable, thus human body valve can be snapped in wherein by groove 432, and then the groove 432 expanded can coordinate with lobe ring position, makes between this Cardiac valve prosthesis and lobe ring more firm.

Above-mentioned lobe leaf 20 is attached at the inner surface of valve bracket 10, and the two ends of lobe leaf 20 are fixed on connecting portion 111.Lobe leaf 20 intersection is concave inward structure, and that so can reduce lobe leaf 20 opens amplitude, thus reduces the probability that lobe leaf 20 blocks up arteria coronaria.As shown in Figure 6, the concave inward structure of lobe leaf 20 intersection, makes the actual scope of opening of lobe leaf 20 be limited in dotted line, decrease valve service time long after, lobe leaf 20 touches the probability of arteria coronaria.

Refer again to Fig. 1, the root of above-mentioned U-shaped opening 30 outwards extends and forms projection 31, this projection 31 suitably can strut the blood vessel of fitting with valve bracket 10, increase the distance between arteria coronaria mouth and lobe leaf 20, further minimizing Cardiac valve prosthesis after long-term use, blocks up the probability of arteria coronaria because of fatigue damage.And the bottom of U-shaped opening 30 arranges the hollow out mouth 32 corresponding with arteria coronaria mouth, thus ensure that blood flow is more smooth and easy, avoids the generation that intermittent arteria coronaria blocks.

In addition, the bottom inward collapsible of lower end 12 and in inner buckle structure, thus lower end can be avoided to oppress atrioventricular node, affect conductive cardiac tissue.

With reference to the structural representation that Fig. 7, Fig. 7 are Cardiac valve prosthesis of the present invention 6th embodiments.Be with the difference of the first to the 5th embodiment: the outer wall of connecting portion 111 is provided with overlay film 112, this overlay film 112 can prevent metal termination from contacting with blood vessel, thus thorn mill blood vessel.

With reference to the structural representation that Fig. 8, Fig. 8 are Cardiac valve prosthesis of the present invention 7th embodiments.Be with the difference of the first to the 6th embodiment: the connecting portion 111 of upper end 11 upwards also arranges extension 113, this extension 113 can better supplemental support at ascending artery place, make this cardiac valve more stable, keeps blood to flow to; And the axial length of valve bracket increases, the rear cardiac valve of valve bracket 10 in use discharging 2/3 is just started working, and now operating doctor can carry out determining whether that withdrawal resets according to cardiac valve working condition and position.

The process of being placed by intervening mode by Cardiac valve prosthesis of the present invention will be described in detail below.

Fixing ear on valve bracket 10 connecting portion 111 (or extension 112) is embedded in the locating slot of valve bracket fixing head outer wall (matching with fixing ear with shape size in the position of locating slot); And then Cardiac valve prosthesis is loaded in outer sheath by sheath pipe in twitching.

By conveyer device, enter through Human Femoral Artery otch, Cardiac valve prosthesis is sent to human aortic valve site.Then discharge Cardiac valve prosthesis, make it location firm.In conveyer device, sheath pipe far-end passes epitheca, pull epitheca just can realize the relative motion of inner and outer tubes, when Cardiac valve prosthesis arrives precalculated position, outer tube is drawn back certain distance, valve bracket 10 part is made to be exposed in human body environment, and first discharge 1/3 of valve bracket 10 length, then d/d part valve support 10 spreading under body temperature effect.Now, the effect in place of valve bracket 10 can be observed according to the situation after spreading.Such as, if find that there is deviation position, then can hold interior sheath, simultaneously, push away epitheca, thus drive valve bracket fixing head.Because the fixing ear of now valve bracket 10 is not also released, it is still in locating slot under the parcel of epitheca, valve bracket fixing head just can pull fixing ear to make valve bracket 10 progress into epitheca, and under the extruding of epitheca inwall, valve bracket 10 can draw in until got back to the state before release by epitheca parcel completely gradually, then reorientate again, discharge, until Cardiac valve prosthesis to be fixed on best position.

The foregoing is only the preferred embodiments of the present invention; not thereby its scope of the claims is limited; every utilize description of the present invention and accompanying drawing content to do equivalent structure or equivalent flow process conversion; directly or indirectly be used in the technical field that other are relevant, be all in like manner included in scope of patent protection of the present invention.

Claims (9)

1. the valve bracket of a Cardiac valve prosthesis, it is characterized in that, described valve bracket is can the elastic support of axial shrinkage, and described valve bracket is Openworks shape, the position of the corresponding lobe leaf of described valve bracket arranges U-shaped opening, and described U-shaped open top end upwards extends and also arranges extension, the root of described U-shaped opening outwards extends, wherein, the U-shaped lower opening portion of described valve bracket is provided with location structure, and the bottom of the U-shaped mouth of described valve bracket is provided with hollow out mouth.

2. valve bracket according to claim 1, is characterized in that, described location structure comprises and being set to the concave by valve bracket and the recessed portion that formed, and described recessed portion is used for coordinating with position of valve, limits the slip of described valve bracket.

3. valve bracket according to claim 1 and 2, is characterized in that, described location structure comprises and outwards to be extended the holding division formed by valve bracket, and described holding division is fastened on position of valve place, limits described valve bracket and slides.

4. valve bracket according to claim 3, is characterized in that, described location structure also comprises the sutural margin positioned in position of valve for valve bracket.

5. valve bracket according to claim 4, is characterized in that, described sutural margin is half drum sutural margin, and the material of this sutural margin is water swelling material; Or described sutural margin is undaform sutural margin.

6. valve bracket according to claim 1 and 2, is characterized in that, described location structure comprises the sutural margin positioned in position of valve for valve bracket.

7. valve bracket according to claim 6, is characterized in that, described sutural margin is half drum sutural margin, and the material of this sutural margin is water swelling material; Or described sutural margin is undaform sutural margin.

8. valve bracket according to claim 6, is characterized in that, the upper end of described valve bracket is provided with connecting portion, form described U-shaped opening, and the outer wall of described connecting portion is provided with overlay film between two adjacent described connecting portions; The lower end of described valve bracket is inner buckle structure.

9. a Cardiac valve prosthesis, is characterized in that, comprises lobe leaf and supports the valve bracket of described lobe leaf, the valve bracket of described valve bracket according to any one of claim 1-8.